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Placebo Effect

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 jj52
(@jj52)
Posts: 75
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Topic starter
 

This week we have learned several different types of clinical studies. Throughout my elementary through high school education we were taught about placebo controlled studies and how patients may be subjected to a placebo effect. A placebo effect is the beneficial effect of sham drug that is due to the patient's belief of receiving the test drug. If patients receiving a sham drug are promoting the same results as patients who are receiving the actually test drug, how can this be explained and differentiated in data? Do you feel that the placebo effect can have negative effects on  a clinical trial? 


 
Posted : 29/10/2023 10:03 am
(@ya282)
Posts: 30
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I'd say short-term data can be influenced by the placebo effect, but keep in mind that placebos don't keep working indefinitely. So, when we look at studies over a longer period, the placebo effect tends to wear off, and we get more accurate results.

Regarding your question about distinguishing the placebo effect from actual treatment in the data, it's a bit of a puzzle in clinical trials. Researchers often use a placebo group to help with this. They compare the folks getting the real deal with those receiving a fake treatment (the placebo) to figure out the real impact of the drug. The placebo effect can muddle things in clinical trials, but with careful study design and statistical analysis, we can manage it.


 
Posted : 29/10/2023 12:44 pm
 an83
(@an83)
Posts: 39
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I would disagree that the placebo effect can have negative effects on a clinical trial. This is because in a clinical trial, there is a difference between a sign and a symptom. Signs are results of illness that are visible to both the provider and the patient while a symptom is only experienced by the provider. Because the experience of a symptom is highly subjective, the data behind clinical trials should be based on signs. The improvement of a patient to a particular treatment should be recorded based on objective metrics, not subjective patient experience. For this reason, as long as clinical trial is obtained in a proper, unbiased manner, there should not be any negative effects on a clinical trial due to the placebo effect


 
Posted : 29/10/2023 2:47 pm
(@shahil)
Posts: 73
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I don't think the placebo effect can have a negative effect on a trial as long as it is documented, additionally if the study is double blind. I think we are good. I think there are a lot of studies that seeks to explore the reasoning behind the placebo effect. However, I think there is still a lot more to learn, though. 

Additionally, I think it all depends on the situation. The placebo might have a positive effect, but maybe not to the same degree as the therapeutic in all situations: or maybe even better. The answer to your question really depends on the situation. 


 
Posted : 29/10/2023 4:45 pm
(@rm829)
Posts: 40
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I completely disagree that placebos are "negative" effects or "sham drugs". I think it's an overall depiction of how much we still don't know about the human body, and how much we rely on pharmaceuticals/procedures when the body can produce a cure/heal on its own. Especially in a double-blind placebo study, it's important to see an accurate representation of how much effect the proposed medication has in comparison to what someone's mindset is when receiving either the "pill". I'd also like to reference a case study (although from 2002) that showed placebo was just as "effective" at relieving pain as an actual knee surgery. This shows the importance of placebo in these trials as it has a much larger impact that some might perceive. I am sure there are plenty of other studies where those in the placebo group even outperformed the tested drug, and these are crucial to determining whether or not that particular medication is even needed.

 

https://pubmed.ncbi.nlm.nih.gov/12110735/  


 
Posted : 29/10/2023 6:27 pm
(@cp527)
Posts: 19
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The placebo effect is a well-documented and intriguing phenomenon in clinical trials. It can be challenging to differentiate the placebo effect from the actual therapeutic effect of a drug, and it has several implications for clinical trials:

  1. Measurement and Control: To differentiate the placebo effect from the true drug effect, clinical trials typically include a control group that receives a placebo (sham treatment) while the other group receives the actual drug being tested. By comparing the outcomes of the two groups, researchers can assess whether the drug has a therapeutic effect beyond what might occur with a placebo.

  2. Baseline Expectations: The placebo effect can be influenced by a patient's expectations and beliefs. If patients believe they are receiving an active treatment, they may experience improvements even if the treatment has no pharmacological effect. Researchers aim to control for these baseline expectations by implementing blinding (participants and often researchers do not know who is receiving the placebo).

  3. Psychological and Physiological Mechanisms: The placebo effect involves both psychological and physiological mechanisms. For example, a patient's belief in a treatment can lead to the release of endorphins, which can provide pain relief. The exact mechanisms are still an area of ongoing research.

  4. Subjective Outcomes: The placebo effect can be particularly significant in trials with subjective outcomes, such as pain, anxiety, or depression. In these cases, it can be more challenging to differentiate between the placebo effect and the actual drug effect.

  5. Ethical Considerations: Placebo-controlled trials are necessary in certain situations, but they raise ethical questions when effective treatments are already available. It may not be ethical to use placebos when a proven treatment exists for a serious medical condition.

  6. Negative Effects on Clinical Trials: The placebo effect can indeed have negative effects on clinical trials, especially when the placebo effect is substantial and blinding is not effective. In such cases, it may be more difficult to demonstrate that the tested drug is genuinely effective, and the trial may yield inconclusive or misleading results.

To address these challenges, researchers carefully design and analyze clinical trials, often incorporating statistical methods to differentiate between placebo and treatment effects. The placebo effect is a critical consideration in the design and interpretation of clinical trials, and researchers aim to account for it to ensure that the results accurately reflect the therapeutic potential of the tested drugs.

 


 
Posted : 29/10/2023 8:48 pm
(@elm33)
Posts: 39
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I have always thought that placebo situations are very interesting but they are usually the case when the researchers tell the patients how the drug should have been effecting the person. The best way to combat that is running a second trial without telling the patients what the drug should do. If nobody can figure out what was beneficial from the drug, this is when I would label the drug as a 'sham drug' as you had said. The human mind is very interesting and sometimes unexplanatory and informed placebos can just happen weirdly. The best way to explain that feeling is when you see a bug and get that skin crawling feeling. You know that bugs are not on you, but think that they are after seeing a real bug. In conclusion, I do think that placebo trials will always have a beneficial effect for studying how to better tune the drug going out.


This post was modified 1 year ago by elm33
 
Posted : 27/10/2024 9:30 pm
(@bsk32)
Posts: 69
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Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insignificant data, with varying responses. Even in the case where some placebo patients have reported symptoms, they are being compared with other placebo subjects who don't report any symptoms. In that case, results will almost always show high deviances between subjects of a placebo group, and conclude that positive results are statistically insignificant, for example, P<0.05. Placebo groups are usually inconsistent in their data, or consistently no reactions. There are many statistical analysis that take place before drawing conclusions directly from the results. 


 
Posted : 27/10/2024 10:45 pm
(@kartikeyakulkarni)
Posts: 29
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The placebo effect creates difficulties in clinical trial result analysis because it demonstrates how mental factors can affect actual physical health results. The brains of patients who receive sham treatments show the same level of improvement as those who receive actual medication because their brains respond through psychological and neurobiological mechanisms including expectation and conditioning and pain modulation. The brain generates approximately 20% of pain control according to class information which demonstrates how beliefs can produce actual symptom improvements. The placebo effect produces positive medical results in actual clinical settings but produces adverse outcomes during controlled clinical trials. The actual effectiveness of the investigational drug becomes hidden through this method which produces untrustworthy study outcomes. The combination of objective measures which include biomarkers and imaging and physiological data with self-reported outcomes provides better understanding of the situation.
The placebo effect demonstrates how mental processes merge with physical body functions to achieve recovery. The research process requires controlling for this factor because it helps scientists confirm drug biological effects by removing psychological elements from trial outcomes.


 
Posted : 21/10/2025 9:12 am
(@riddhiramesh)
Posts: 30
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In my opinion, the placebo effect does not have negative effects on a clinical trial. The placebo is the control, which is compared against the actual drug/medication that is given. If a patient in a clinical trial is given the placebo and they think that they are taking the drug/medication, and they think they are getting better, that doesn’t have any negative effect on the clinical trial. It could have negative effects on the patient after the trial is over if they are told that they got the placebo. If the study is a triple-blind study, the placebo effect might make it confusing for scientists to figure out which patients had the drug and which patients had the placebo.


 
Posted : 21/10/2025 3:12 pm
(@cn249)
Posts: 27
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Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that placebo effects can skew data results in pharmaceutical drug research and testing even if it is in a controlled manner or well-documented. Patients who have signed and are participating in the trial are aware of the new drug or medicine that they are receiving. They are under the notion that this drug will do something to their body, but they do not know what. They are under the psychological influence of taking a new drug and to see what happens to their body. It can be good, neutral, or bad. If you tell someone they will feel relief or calm after taking the new drug, they may actually feel calm even if the drug was a placebo. It would cause false data collection and signs in the trials. This places the idea into your head that this fake drug you do not know you are receiving will help your body and you will feel it. They expect the positive reaction to happen in the treatment. Regarding patients that receive the sham drug and promote the same results as patients who are receiving the actual test drug, this can be explained from the psychological effects. As said before, they have been notified and signed an informed consent to what they are testing and taking. They may hype themselves up and start to believe that when they take this drug, it will help them feel better. That could potentially be one explanation. Another way to explain the results and differentiate them is to perform a design of experiments. This should be randomized and controlled. There would be two groups; one receiving the actual drug and one receiving the sham drug. To make it non-biased, the clinical trials could be single blinded or double blinded. Double blind may be the best option to promote non-biased testing as the doctor does not know what drug is being administered and the patient does not know what they got. From there, once the experiment is completed, they can perform a statistical analysis on the results. From there, they can observe the charts, statistical analysis, and R squared value to see which group had the “best” treatment or effect. Once they figure out which group had the positive effect, that would be the experimental group compared to the placebo. But if both groups have the same reaction to the placebo and the treatment, then the new drug does not work.
Clinical research data is almost the same as collecting data for any type of research in industry and in academia. There are many articles from Harvard that mention placebo effects and their impact on clinical data and research. As I said, I believe that the placebo effect can negatively affect clinical data and decision making to see if the new drug being tested is accurately helping or not. From many Harvard articles, they mention how placebo drugs can either have a positive effect for the trial or a negative effect that can affect the patient. They say “a powerful placebo effect makes it harder for researchers to prove that a new medication is effective”. This is true based on what I had mentioned before that if both groups have similar reactions to the new drug and placebo drug, then the treatment is deemed null or ineffective. Patients have high expectations that they are contributing to science and helping people in the long run by participating in clinical research. They expect this newfound drug to be extremely helpful even if they receive the placebo. There is also the concept of nocebo effect which is the negative effect of the placebo. If patients are experiencing negative effects of the placebo based on what they read and are notified about before agreeing to the trial, then this can affect data collection. The patients may opt to withdraw from the clinical trial for any reason, such as this, and whenever they want to, even during testing. That is a part of data collection and missing subject data can be an issue. 


 
Posted : 22/10/2025 10:32 pm
(@natalie-nashed)
Posts: 27
Eminent Member
 

I think another interesting angle that hasn't been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in data collection. In some cases, the way a doctor communicates confidence or empathy can unintentionally enhance placebo responses. That makes me wonder if clinical trials could measure not only the drug's biological effect but also how much human factors (like trust or reassurance) play a role in healing. Considering that, the placebo effect isn't just a "problem" to control for, but a tool for understanding the mind to body connection. Modern studies are even starting to test "open-label" placebos, where patients know they're taking a placebo but still show improvements. That kind of result changes how we think of treatments altogether. So, while the placebo effect might make statistical analysis more difficult, it also helps scientists learn more about how belief, expectation, and encouragement influence recovery. I think that's something worth appreciating instead of just minimizing in trials.


 
Posted : 23/10/2025 1:55 pm
NCarrillo reacted
(@vbp098)
Posts: 27
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I agree with what has been said about negative results if the placebo effect seems to be helping patients because it seems to disprove the actual use of the medication. If the placebo group were to do better in comparison or even equally as well as the drug, then it does not make sense to use the medication as there are going to be unnecessary side effects. The idea of a placebo is useful just to ensure that the mediation is working as it should be and not because there is simply hope. The mind is quite a powerful thing in helping people feel better, that sense of hope for a lot of patients is sometimes enough, so if there are overly positive results simply from the placebo the medication is clearly just providing hope. It is quite fascinating though because if doctors know that a placebo is enough are they allowed to sell it as in market a device that clearly under performed a placebo group and in a way maybe offer patients aid. There would definitely be some ethical issues behind that method. I think people underestimate how much hope can help someone, so if a placebo seems to work that is the case. However, even if it is not performing as it should, but if someone is feeling better or in their mind they are getting better, then it is still beneficial. The medication needs to be tested, but if at the same time it is able to provide patients with a sense of relief it is quite useful. 

I do agree that a double-blind study may help, but because a company wants to pass FDA regulations it is still possible for the people involved to skew the data analysis in one way over another. Thus, it would be beneficial for the people if the study was actually triple blind so that there is no way to tell who is receiving what medication. Limiting the unnecessary bias can help to get much more accurate data because there is less of a chance of someone manipulating the data.  


 
Posted : 24/10/2025 5:14 am
(@agebraeil)
Posts: 28
Eminent Member
 

The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug or the belief in the treatment. The psychological response can hide the effectiveness of a medication, this is especially true if the the treatment group and the placebo group show similar results. Researchers use double blind studies to minimize the complications that come with the placebo group. Understanding the placebo effect is important to ensure reliable and valid results in clinical research


 
Posted : 24/10/2025 9:22 am
(@nick-carrillo)
Posts: 27
Eminent Member
 

Unlike a good portion of the responses here, I believe the placebo effect is a reliable way to keep patients and researchers from having implicit expectations relating to the response to the given drug sample. It yields more accurate data that will help researchers gain valuable insight into the real treatment’s functionality and determine what needs to be kept, removed, or improved, all while eliminating functional bias. Without it, the effectiveness of a medication would be based on one sample population that may not be representative of most potential candidates, limiting the ability to distinguish information between the neutral and treated sample groups. 

When patients are given a sugar pill and begin to present these symptoms as a result of the placebo effect, they might not improve as much as they think they are. That is, they might feel less of a specific symptom or more, but their biological response would not show much difference. Conversely, patients given the real drug will likely experience more pronounced effects upon taking a dose, which, when documented and compared to the placebo trials, will give researchers a better idea of how well the medication truly performs. In short, the placebo effect is a way to reduce any assumptions/bias by patients and measure the drug’s efficacy against a neutral, psychologically-influenced response, giving researchers a baseline to make conclusions about the effectiveness of the treatment.

It is worth noting that there are two distinct psychological responses to stimuli, especially for clinical trials. One is the aforementioned placebo effect, which involves positive responses resulting from positive expectations. The second is the nocebo effect, involving negative responses resulting from negative expectations. Both are crucial to understanding the outcomes of a prospective treatment, especially when side effects are not well understood. As such, it is plausible that some patients may not have as many positive assumptions towards the treatment as others, which influences the symptoms (or lack thereof) they will/will not present. This information gives researchers the ability to gauge the negative and positive psychological influences of the treatment to interpret and utilize the data more effectively.


 
Posted : 24/10/2025 7:05 pm
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